FDA Regulatory Affairs Officer
Kittelson & Carpo Consulting
- Taguig, Philippines8F Marajo Tower, 26th Street corner 4th Avenue, BGC, Taguig, Metro Manila, PhilippinesTaguigMetro ManilaPhilippinesPhilippines
- Penuh waktuFULL_TIME
Berakhir 5 years ago
2019-06-30T16:00:00+00:00Ditutup.
Deskripsi Pekerjaan
- Meet with potential FDA clients, discuss the FDA registration requirements, fees, and other relevant information and send K&C service proposal.
- Coordinate, compile, organize, and review client’s documents for pre-submission to FDA
- Oversee quality control of regulatory documents and submissions
- Submit and monitor applicable documents/reports to FDA and ensure appropriate responses are submitted to FDA when necessary
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Monitor applications for regulatory review
- Compile and maintain regulatory documentation databases or systems and fill-out the FDA client and inquiry tracker shared with the LCD manager and marketing team.
- Develop or conduct employee regulatory training.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Interpret regulatory rules or rule changes and ensure that they are communicated with the potential clients, existing clients, and legal compliance manager.
Kualifikasi Minimum
- Candidate must be a registered pharmacist
- Must be knowledgeable with FDA process and registration of food and food supplements, medical devices, drugs, and hazardous products, and their regulatory rules.
- At least 1 year of relevant working experience in the same field.
- Applicant must be willing to work in BGC
Ringkasan Perkerjaan
- Tingkat Posisi
- Supervisor / Asisten Manager
- Spesialisasi
- Management and Consultancy
- Persyaratan tingkat pendidikan
- Lulus program Sarjana (S1)
- Respon rekruter ke lamaran
- Always
- Alamat Kantor
- 8F Marajo Tower, Taguig, Metro Manila, Philippines
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Tentang Kittelson & Carpo Consulting
Kittelson & Carpo Consulting provides assistance to companies setting up and doing business in the Philippines.
In the last ten years, K&C has advised and registered more than a thousand companies in the Philippines, more than any other firm in the country. We offer the exact services a foreign company or investor needs to set up operations quickly and efficiently.
We recently expanded our regional presence in Southeast Asia through In.Corp Group’s acquisition of our business consulting firm in December 2017. In.Corp Group is the leading provider of professional corporate solutions for local and multinational businesses in Singapore looking to establish their branch office or expand their corporate operations into the country. The company has regional presence in seven Southeast Asian countries, including India and China. This significant progress is our newest attempt to build an expansive global network and integrate a cross-border market insight into our services.